JOHN L HAYS: So one of the enduring questions, whenever we see outcomes like this in a disease such as ovarian cancer, which is in platinum-resistant ovarian cancer, which is a debilitating disease, is, how do we move forward with really exciting data into the next stage of clinical development? Should we take this to a phase II trial? Should we go straight to a phase III trial?
And there is not an exact right answer to that question. And I think you can have good arguments for doing a phase II trial versus going straight to a phase III trial, when you see such promising responses like this. Ultimately, the decision was made to proceed straight to a phase III trial, which then raises lots of questions about, how do you design that phase III trial? What was the relative contribution of Nemvaleukin to the overall response in the combination therapy?
We kind of know what the response rate was to pembrolizumab because we've studied pembrolizumab in the platinum-resistant space. But again, the combination, are these two drugs additive? Are they cooperative? Does each one have some individual signal that we need to see? And these are all questions that need to be answered when you want to design a phase III trial, to get the most information out of the smallest number of patients possible.
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Actually, that's an interesting question that a lot of people are arguing about right now. And so what we found is that some drugs-- well, historically, the way we've developed drugs in ovarian cancer is we all start in the platinum-resistant space. And if we see a signal, then we push it forward to earlier stages of disease, including platinum-sensitive or frontline.
What we now really understand is platinum-sensitive ovarian cancer and platinum-resistant ovarian cancer are two completely different diseases. And if you see a signal, there's no real reason you need to wait and do a big platinum-resistance trial to push it forward into the platinum-sensitive setting. 10 years ago, had you said that exact sentence, you'd have gotten yelled out of a room, and nobody would have listened to you, for fear of being crazy.
Nowadays, there actually are some trials that are looking at that. When they see a small signal, they think, look, we have laboratory models that say, this is even better than platinum sensitive. We don't feel like we're going to get much of a signal in platinum resistance, so we're going to go straight to the platinum-sensitive setting. It's been an interesting change. And that's really only been in the last year or two that those trials are being proposed.
